UI Hospitals and Clinics

Clinical Trial Details

Short Title
Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Official Title

A randomized phase II study of Azacitidine in combination with Lenalidomide (NSC-703812) vs Azacitidine alone vs Azacitidine in combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Description

Participants in this research study have a higher risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). This means that the participants' bone marrow does not create enough of at least one type of blood cell that their bodies need.

The purpose of this research study is to compare the effects, good and/or bad on the MDS or CMML, of adding either the drug lenalidomide or the drug vorinostat to the regular treatment drug azacitidine. Participants in this study will be on one of the following treatment arms: azacitidine alone, azacitidine and lenalidomide or azacitidine and vorinostat. Participants only receive one of these study treatments.

Azacitidine and lenalidomide are approved by the U.S. Food and Drug Administration (FDA) for the treatment of MDS, or one of its subtypes. The combination of azacitidine with the drug lenalidomide or with the drug vorinostat (as they are being used in this study) are both considered experimental, which means that they are not FDA approved for the treatment of MDS or CMML.

Approximately 9 people will take part in this study conducted by investigators at the University of Iowa. Approximately 267 people will take part in this study nationwide.

Start Date
January 23, 2013
End Date
January 23, 2023
Gender Preference
None
Age Group
18 - 99 years
Principal Investigator
Thomas Carter, MD, PhD
Contact Info

Janan Geick-Miller, 319-356-3944

Department
Department or Field of Study
Keywords
azacitidine ; cancer ; carter ; chronic myelomonocytic leukemia (CMML) ; IRB#201210845 ; lenalidomide ; myelodysplastic syndrome ; phase 2 ; phase II ; S1117 ; undefined ; vorinostat ;

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